NCT06415305

A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne

The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Acne vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation. Data is limited for skin of color patients in Phase III registration trials. Data is limited because there are few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Winlevi (clascoterone) 1% cream	Dosed twice daily (BID)

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-04-17
• Completion: 2025-01-30
• First posted: 2024-05-16
• Last updated: 2026-01-16
• Results posted: 2025-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study